Device product
PedFuse Bone Probe; Part: SI81008 spinal pedicle fixation.
Z-0624-2014
Product summary
- Event
- Event 66273
- Status
- Terminated
- Classification
- Class II
- Quantity
- 13 devices
- Official record key
device-enforcement:Z-0624-2014
Official wording
Reason: Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications.
Code information: Lot: 012212-001
Distribution pattern: US Distribution: including states of: TX and VA.
Derived failure modes
-
Unknown
Bone Probes used to create a pathway in pedicle bone were manufactured and marked to incorrect specifications.